Ventricular ArrythmiaNCT04809701
Non-vascular ICD Electrode Configuration Feasibility Study
A study testing Temporary implantation of defibrillation coils and pulse generator, Defibrillation following induction of VA (Configuration A first) and Defibrillation following induction of VA (Configuration B first) in people with Ventricular Arrythmia, run by Abbott Medical Devices at 3 sites in 3 countries.
Trial summary
This study is designed to evaluate the energy requirements of two different Nonvascular ICD (NV-ICD) electrode configurations for achieving successful defibrillation of ventricular arrhythmias. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Arrythmia
- What is being tested?
- Temporary implantation of defibrillation coils and pulse generator, Defibrillation following induction of VA (Configuration A first) and Defibrillation following induction of VA (Configuration B first)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 22 Mar 2021to 24 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient that is scheduled to undergo surgery requiring midline sternotomy or implantation of a commercially-available TV-ICD or S-ICD system per local guidelines
- Patient must be at least 18 years of age
- Subject must provide written informed consent prior to any clinical investigation-related procedure.
Who cannot join
- Pacemaker dependency
- Chronically implanted cardiac implantable electronic device or other device which delivers an electrical current
- Currently taking amiodarone or a Class IC antiarrhythmic drug
- Hypertrophic cardiomyopathy
- Anticipated high risk of stroke
- Anticipated high surgical risk or risk of infection
Show all 15Show fewer
- Severe aortic stenosis
- Severe proximal three vessel coronary disease (over 70% in each vessel)
- Greater than 50% left main stem disease
- Prior surgery or anatomical abnormality that significantly increases implant risk per physician's discretion
- Medical conditions that preclude defibrillation testing
- Chronic renal insufficiency including patients on dialysis
- Subject is currently participating in another clinical investigation.
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with the 1-month phone follow-up requirements of the clinical investigation results.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Paraguay1 site
Centro de Intervenciones Endovasculares y Cirugía Cardiovascular
Asunción, Asuncion
About this study
Official title: Evaluation of Different Defibrillation Electrode Configurations for Development of a Non-vascular ICD
This study is designed to evaluate the energy requirements of two different Nonvascular ICD (NV-ICD) electrode configurations for achieving successful defibrillation of ventricular arrhythmias.
- Conditions
- Ventricular Arrythmia
- Being tested
- Temporary implantation of defibrillation coils and pulse generator, Defibrillation following induction of VA (Configuration A first), Defibrillation following induction of VA (Configuration B first), Removal of defibrillation coils and pulse generator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary implantation of defibrillation coils and pulse generatorProcedure or surgery
Each subject will undergo temporary implantation of defibrillation coils and pulse generator according to the NV-ICD electrode configurations.
Defibrillation following induction of VA (Configuration A first)Procedure or surgery
Ventricular arrhythmia (VA) will be induced via an EP catheter placed in the right ventricle. After VA is confirmed, a defibrillation shock will be attempted to terminate the arrhythmia. Up to two defibrillation energies will be tested for Configuration A. Then up to two defibrillation energies will be tested for Configuration B.
Defibrillation following induction of VA (Configuration B first)Procedure or surgery
Ventricular arrhythmia (VA) will be induced via an EP catheter placed in the right ventricle. After VA is confirmed, a defibrillation shock will be attempted to terminate the arrhythmia. Up to two defibrillation energies will be tested for Configuration B. Then up to two defibrillation energies will be tested for Configuration A.
Removal of defibrillation coils and pulse generatorProcedure or surgery
Defibrillation coils and pulse generator will be removed from the subject after the defibrillation tests are completed.
| Study group | Role | What they receive |
|---|---|---|
| Configuration A first | Experimental | Subjects receive the test of Configuration A first and Configuration B second. Receives: Procedure: Temporary implantation of defibrillation coils and pulse generator; Procedure: Defibrillation following induction of VA (Configuration A first); Procedure: Removal of defibrillation coils and pulse generator |
| Configuration B first | Experimental | Subjects receive the test of Configuration B first and Configuration A second. Receives: Procedure: Temporary implantation of defibrillation coils and pulse generator; Procedure: Defibrillation following induction of VA (Configuration B first); Procedure: Removal of defibrillation coils and pulse generator |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of successful defibrillation of induced VA using each of the two NV-ICD electrode configurations
Successful defibrillation is defined as termination of the induced VA to sinus rhythm or other non-life threatening ventricular or escape rhythm (such as atrial fibrillation) as determined by the implanting physician.
Measured: During the study procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start22 Mar 2021
- Primary completion7 Dec 2021
- Study completion24 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrythmiaStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reinoud E Knops, MD, PhD, Principal investigator, Academic Medical Center Department of Cardiology Meibergdreef 9 1105 AZ Amsterdam The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809701
- Sponsor's protocol ID
- ABT-CIP-10369
- Status last verified
- Oct 2022
- First submitted
- 17 Mar 2021
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Defibrillation Electrode Configurations for Development of a Non-vascular ICD
- ClinicalTrials.gov ID
- NCT04809701
- Acronym / sponsor ID
- ABT-CIP-10369
- Conditions
- Ventricular Arrythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 24 Mar 2022 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the energy requirements of two different Nonvascular ICD (NV-ICD) electrode configurations for achieving successful defibrillation of ventricular arrhythmias.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Configuration A first | Experimental | Procedure: Temporary implantation of defibrillation coils and pulse generator, Procedure: Defibrillation following induction of VA (Configuration A first), Procedure: Removal of defibrillation coils and pulse generatorSubjects receive the test of Configuration A first and Configuration B second. |
| Configuration B first | Experimental | Procedure: Temporary implantation of defibrillation coils and pulse generator, Procedure: Defibrillation following induction of VA (Configuration B first), Procedure: Removal of defibrillation coils and pulse generatorSubjects receive the test of Configuration B first and Configuration A second. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient that is scheduled to undergo surgery requiring midline sternotomy or implantation of a commercially-available TV-ICD or S-ICD system per local guidelines
- Patient must be at least 18 years of age
- Subject must provide written informed consent prior to any clinical investigation-related procedure.
Key exclusion criteria (15 listed)
- Pacemaker dependency
- Chronically implanted cardiac implantable electronic device or other device which delivers an electrical current
- Currently taking amiodarone or a Class IC antiarrhythmic drug
- Hypertrophic cardiomyopathy
- Anticipated high risk of stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporary implantation of defibrillation coils and pulse generatorEach subject will undergo temporary implantation of defibrillation coils and pulse generator according to the NV-ICD electrode configurations. | Procedure or surgery | Configuration A first, Configuration B first |
| Defibrillation following induction of VA (Configuration A first)Ventricular arrhythmia (VA) will be induced via an EP catheter placed in the right ventricle. After VA is confirmed, a defibrillation shock will be attempted to terminate the arrhythmia. Up to two defibrillation energies will be tested for Configuration A. Then up to two defibrillation energies will be tested for Configuration B. | Procedure or surgery | Configuration A first |
| Defibrillation following induction of VA (Configuration B first)Ventricular arrhythmia (VA) will be induced via an EP catheter placed in the right ventricle. After VA is confirmed, a defibrillation shock will be attempted to terminate the arrhythmia. Up to two defibrillation energies will be tested for Configuration B. Then up to two defibrillation energies will be tested for Configuration A. | Procedure or surgery | Configuration B first |
| Removal of defibrillation coils and pulse generatorDefibrillation coils and pulse generator will be removed from the subject after the defibrillation tests are completed. | Procedure or surgery | Configuration A first, Configuration B first |
Primary outcome
The rate of successful defibrillation of induced VA using each of the two NV-ICD electrode configurations
Time frame: During the study procedure
Successful defibrillation is defined as termination of the induced VA to sinus rhythm or other non-life threatening ventricular or escape rhythm (such as atrial fibrillation) as determined by the implanting physician.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Ventricular Arrythmia
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EDEN Intracardiac Electrogram Recording and Classifying System
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reinoud E Knops, MD, PhD principal investigator
Academic Medical Center Department of Cardiology Meibergdreef 9 1105 AZ Amsterdam The Netherlands
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary implantation of defibrillation coils and pulse generator, Defibrillation following induction of VA (Configuration A first) and Defibrillation following induction of VA (Configuration B first) in people with Ventricular Arrythmia, run by Abbott Medical Devices at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Chile, Czechia, Paraguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of successful defibrillation of induced VA using each of the two NV-ICD electrode configurations (time frame: During the study procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.